Soft Sensor Large WO2 Model 8000SL-WO2

GUDID 00849686050998

Model 8000SL-WO2, Soft Sensor Large WO2, Philips, Reusable Pulse Oximeter Soft Sensor

NONIN MEDICAL, INC.

Pulse oximeter probe, single-use

• Primary Device ID: 00849686050998
• NIH Device Record Key: 81e0d506-38a6-4a67-9b8a-3717037c8c06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soft Sensor Large WO2 Model 8000SL-WO2
• Version Model Number: 8000SL-WO2
• Company DUNS: 174959692
• Company Name: NONIN MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849686050998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092101

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-13
• Device Publish Date: 2021-04-05

Devices Manufactured by NONIN MEDICAL, INC.

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• 00833166000139 - PALMSAT HANDHELD OXIMETER: 2024-09-18 PALMSAT HANDHELD OXIMETER with 8000SM-3
• 00833166000146 - PALMSAT HANDHELD OXIMETER: 2024-09-18 PALMSAT HANDHELD OXIMETER with 8000SL sensor